Ear insert for relief of TMJ discomfort and method for use thereof

ABSTRACT

A prosthesis for insertion in an ear to reduce pain resulting from TMJ disorders. The ear insert has a predefined shape conforming to the shape of the ear canal when the jaw is in an open position. The ear insert supports the TMJ and associated secondary musculature to reduce strain in the TMJ area, including the muscles, ligaments, nerves, and the temporo-mandibular joint itself. The insert is hollow in the inside to permit hearing and is made of a rigid material which retains the shape of the ear canal. A scalloped indenture extends across a surface of the ear insert positioned behind the tragus.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of application Ser. No. 13/312,529,filed Jun. 7, 2013, now U.S. Pat. No. 9,339,376, which is a continuationof application Ser. No. 13/215,188, filed Aug. 22, 2011, now U.S. Pat.No. 8,460,377 which is a division of application Ser. No. 12/075,046,filed Mar. 7, 2008, now U.S. Pat. No. 8,002,829, all of which areincorporated by reference herein.

TECHNICAL FIELD

The present disclosure relates generally to medical devices, and moreparticularly, to medical devices for alleviation of jaw discomfort.

BACKGROUND

Many people suffer from pain in the joint located between the skull andthe jaw. The joint is formed between the temporal bone of the skull andthe mandible or jaw bone, and is commonly known as thetemporo-mandibular joint or “TMJ”. The human body has twotemporo-mandibular joints, one located on each side of the jaw in frontof each ear. The TMJs move every time a person chews, talks, orswallows.

In greater detail, the TMJ is a paired joint articulating the mandibularcondyle, articulator disc, and squamous portion of the temporal bone.The TMJ is capable of both glide and hinge movements. Specifically, theTMJ is formed by the mandibular condyle fitting into the mandibularfossa of the temporal bone. A separation of these two bones isaccomplished by the articulator disc which is composed of dense fibrousconnective tissue. Ligaments attach the articulator disc to the condyle,permitting rotational movement of the articulator disc during mouthopening and closure.

Displacement of the articulator disc introduces strain to the jawmuscles and causes muscle pain or fatigue around the jaw. In addition,articulator disc displacement often causes a painful clicking in the TMJduring certain jaw movements as the disc moves between normal anddisplaced positions. A number of other symptoms may occur as a result ofa strained disc, including TMJ lock, shoulder, neck, and back pain, andheadaches.

Unfortunately, conventional methods of treating temporo-mandibular jointdisorders can be costly, physically cumbersome, involve invasive andirreversible treatment or be time consuming. Some conservative methodsfor treating TMJ discomfort include the use of an intra-oral splint,medication, and life style changes. One type of intra-oral splint is astabilization apparatus which is used to help alter the posture of themandible to a more open, relaxed, resting position. Another type ofintra-oral splint is an anterior positioning apparatus. The anteriorpositioning apparatus attempts to decrease the compression load on thejoint and alter the structural condyle disc relation. Both types ofsplints, however, cannot be used full time without risking displacementof teeth. Treatment by medication often involves the use of addictivedrugs and/or anti-depressants and therefore can lead to misuse andabuse. In addition, medications often produce adverse side effects inthe patient. Other conservative methods include chiropractic or physicaltherapy. Unfortunately, these methods require extensive time commitmentsand physical exertion by the patient.

More aggressive treatment of TMJ discomfort includes orthodontictreatment such as grinding down of teeth and various types of surgery.Orthodontic treatments, however, merely indirectly address TMJ pain byadjusting the dental articulation and overall bite of the patient.Furthermore, orthodontic approaches are invasive, irreversible, andexpensive.

An alternative procedure and related apparatus for treatment of TMJdiscomfort are disclosed in U.S. Pat. No. 5,769,891, the contents ofwhich are incorporated by reference herein in their entirety. Accordingto the disclosure in U.S. Pat. No. 5,769,891, a prosthesis is providedfor insertion into the ear canal. The prosthesis has a rigid structuralportion of a shape conforming to the ear canal when the jaw is in anopen position. The prosthesis provides added support to the TMJ andassociated secondary musculature to reduce strain in the TMJ area.

SUMMARY OF THE DISCLOSURE

According to one aspect, the present disclosure provides an ear canalinsert for treating TMJ disorders which acts directly on the TMJ andassociated ligament and muscle structures to reduce stress and loadsplaced on the articulator disc located between the temporal bone and themandible, as well as supportive muscles and ligaments near the TMJ. Theinsert includes a base portion adapted to reside adjacent the opening ofthe ear canal with a portion of the base support extending into theinter-tragal notch to reside at a position between the tragus andanti-tragus portions of the outer ear following insertion. The baseportion further includes a scalloped indenture extending away from aboundary edge of the base portion across an outwardly facing lateralsurface of the insert.

According to another aspect, the present disclosure provides an earcanal insert for treating TMJ disorders which acts directly on the TMJand associated ligament and muscle structures to reduce stress and loadsplaced on the articulator disc located between the temporal bone and themandible, as well as supportive muscles and ligaments near the TMJ. Theinsert includes a base portion adapted to reside adjacent the opening ofthe ear canal following insertion. At least one anterior projecting postelement projects outwardly away from a boundary edge of the base portionto a position outside of the ear canal to facilitate insertion andremoval of the insert.

These and other aspects of the disclosure will become more apparent fromthe following detailed description when taken in conjunction with theaccompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an isometric view of an exemplary prosthesis for insertioninto an ear canal for treatment of TMJ discomfort;

FIG. 2 is a view illustrating an outer ear;

FIG. 3 is cut-away side view of the prosthesis of FIG. 1 inserted intoan ear canal;

FIG. 4 is a side view of a TMJ in an unoccluded position showing a discin the normal position; and

FIG. 5 is a side view of a TMJ in the closed position showing a disc inthe displaced position.

While the concepts of the instant disclosure are susceptible to variousmodifications and alternative constructions, certain illustrativeembodiments thereof have been shown in the drawings and will bedescribed below in detail. It should be understood, however, that thereis no intention to limit the invention to the specific forms disclosed,but on the contrary, the intention is to cover all modifications,alternative constructions and equivalents falling within the spirit andscope of the disclosure as defined by the appended claims and allequivalents thereto.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

Exemplary constructions and practices will now be described throughreference to the drawings, wherein like elements are designated by likereference numerals in the various views. For purposes of illustration,FIG. 1 illustrates a prosthesis 10 adapted for insertion into an earcanal 12 as shown generally in FIG. 3. According to a contemplatedpractice, the prosthesis 10 includes a hollow structural body portion 14molded from a substantially rigid material such as acrylic or the like.Accordingly, the structural body portion 14 is substantiallyincompressible and maintains its shape upon insertion.

In the illustrated construction, the structural body portion 14 issubstantially hollow along its length to facilitate sound transmission.The structural body portion 14 has a three-dimensional exterior shapecorresponding substantially to the shape of ear canal 12 when a user'smouth is in an open position. Thus, following insertion of theprosthesis 10, the structural body portion 14 is in substantiallyconforming relation relative to contours at the inner surface of the earcanal 12 such that the prosthesis 10 is held in a substantially nestedrelation relative to the interior surface of the ear canal 12. Ifdesired, one or more additional compressible cushioning layers (notshown) may be provided around at least apportion of the rigid structuralbody portion 14. However, such a cushioning layer is in no wayessential. By way of example only, and not limitation, materials forforming such a cushioning layer may include PVC, silicone or the like.

As shown in the illustrated construction, the structural body portion 14includes a proximal base portion 16 and a distal end portion 18. Theproximal base portion 16 is of greater diameter than the distal endportion 18. As best illustrated in FIG. 3, the proximal base portion 16is adapted to be positioned in inserted relation substantially adjacentthe opening of ear canal 12. In the illustrated construction, theproximal base portion 16 includes an extended peninsular leg portion 19adapted to project generally downwardly when the structural body portion14 is in inserted position within the ear canal 12. In this regard, thepeninsular leg portion 19 projects into the inter-tragal notch 21 shownin FIG. 2 adjacent to the tragus 36 and the opposing anti-tragus 38portions of the outer ear. The distal end portion 18 of the structuralbody portion 14 is adapted to extend approximately to the bend in theear canal known as the isthmus 22. The isthmus 22 is in close proximityto the temporo-mandibular joint and is located approximately 20-22millimeters from the outside of an adult ear. However, this distance mayvary in different individuals.

As best illustrated through joint reference to FIGS. 1 and 3, accordingto the illustrated construction, a scalloped indenture 30 extends awayfrom an edge of the proximal base portion 16. In this regard, it iscontemplated that the scalloped indenture 30 may be formed by anysuitable technique as may be desired. By way of example only, and notlimitation, one such technique involves post-formation sculpting usingcutting tools or the like although other techniques may be used asdesired. As shown, the scalloped indenture 30 extends generally towardsthe distal end portion 18 and is positioned across a surface of thestructural body portion 14 adapted reside immediately behind the tragus36 and opposing anti-tragus 38 of the outer ear. It is contemplated thatthe scalloped indenture 30 may have a length and width suitable toaccept substantially the entire lobe of the tragus 36 therebyfacilitating the ability of the tragus 36 to bend inwardly towards theopening of ear canal 12 substantially without obstruction. Surprisingly,it has been found that the structural body portion 14 incorporating sucha scalloped indenture 30 maintains its structural integrity to providejaw support as described further hereinafter despite the substantialreduction in supporting material.

According to the illustrated construction, it is contemplated that atleast one anterior projecting post element 40 may extend away from asurface of the peninsular leg portion 19. As shown, the post element 40projects in a direction extending generally away from the distal endportion 18 so as to project towards the exterior of the ear. Followinginsertion, at least a portion of the post element 40 may reside outsideof the ear canal 12 at a position within the vicinity of theinter-tragal notch 21. In this position, a wearer may grasp the postelement 40 to facilitate removal of the insert.

The post element 40 is preferably substantially pliable to enhanceinsertabilty and removability and to avoid discomfort to the wearer. Atthe same time, the post element 40 should be characterized by sufficientstrength to avoid breakage. By way of example only, and not limitation,it has been found that a suitable post element 40 may be formed fromthermoplastic monofilament nylon adhesively bonded onto a surface of thepeninsular leg portion 19. However, other suitable polymeric ornon-polymeric materials may likewise be utilized if desired.

As shown, the post element 40 may include a bulbous head portion 41.Such a bulbous head portion 41 may enhance the ability of a wearer tograsp the post element 40 during removal of the prosthesis 10 from theear canal 12. In the event that the post element 40 is formed from nylonor other thermoplastic material, a suitable bulbous head portion 41 maybe formed by selectively melting the terminal end of the post element 40to form a melted polymer bead which is thereafter permitted toresolidify. The surface of the resolidified bead may thereafter besmoothed by sanding or other suitable treatment to remove irregularitiesso as to enhance comfort during use.

Referring now to FIGS. 4 and 5, the use of the prosthesis 10 influencesthe relationship between the temporal bone 44 and the mandible 46 ineach temporo-mandibular joint 48, thereby relieving pain inducing stressin the temporo-mandibular joint 48 and related muscles, ligaments, andnerves. In this regard, it will be appreciated that one source oftemporo-mandibular joint discomfort is a dislocated articulator disc 50.As shown in FIG. 4, when the jaw or mandible 46 is in an open orunoccluded position corresponding to the mouth being open, thearticulator disc 50 is usually in a normal, unstrained position betweenthe temporal bone 44 and a condyle surface of the mandible 46. As isoften the case with a person experiencing temporo-mandibular jointdiscomfort, the articulator disc 50 slips to a displaced position whenthe mandible 46 is subsequently closed, as illustrated in FIG. 5. Thedisplacement of the articulator disc 50 is often indicated by a clickingor popping noise as the mandible 46 moves between open and closedpositions. In the displaced position, the articulator disc 50 is nolonger between the condyle surface and the temporal bone 44, and thearticulator disc 50 and attached ligaments become strained. Strain onthese members stresses the surrounding muscles, which may ultimatelyresult in face, neck, and back pain.

To treat temporo-mandibular joint discomfort arising from a displacedarticulator disc 50, the prosthesis 10 is provided for reducing stressesand loads on the articulator disc 50. The prosthesis 10 reshapes the earcanal and provides a rigid structure which helps align thetemporo-mandibular joint 48 and associated muscle and ligamentstructures so that the temporo-mandibular joint 48 has a normalrotational movement . Strain or compression on the articulator disc 50is therefore reduced, thereby alleviating pain in the temporo-mandibularjoint and associated structures.

It is to be understood a dislocated disc is only one cause oftemporo-mandibular joint discomfort and that there are many othersources of such pain. Nerves, ligaments, and muscle groups (such as themasticatory musculature) are located proximal to the temporo-mandibularjoint, and improper loading, strain, or alignment of these membersprovide potential sources of temporo-mandibular joint pain. Rather thanbeing limited to disc dislocation situations, as outlined above, theprosthesis 10 addresses misalignment and stress in thetemporo-mandibular joint and related structures by supporting thesestructures for normal rotational movement.

It will be appreciated that the prosthesis 10 alleviatestemporo-mandibular joint discomfort by supporting the temporo-mandibularjoint 48 and associated muscles, nerves, and ligaments for properrotation of the mandible between open and closed positions. Theprosthesis 10 is formed to correspond to the shape of the ear canal 12when the mandible 46 is open and disc 50 is in the normal position. Whenthe mandible 46 is subsequently closed, the prosthesis 10 maintains thepositioning of the mandible 46 the so that the disc 50 is not displaced.Accordingly, a natural body orifice is used to reposition the mandible46 without requiring surgery or other painful and invasive techniques.As noted above, the example of a dislocated disc is merely illustrativeof a temporo-mandibular joint condition addressed by the present deviceand is in no means meant to limit the scope of the present invention.Accordingly, it will be appreciated that the present device addressesstresses and misalignments in not only the disc but also any muscles,ligaments, and nerves associated with the temporo-mandibular joint.

It will be appreciated that the foregoing description provides examplesof the disclosed apparatus and method of use. However, it iscontemplated that other implementations of the disclosure may differ indetail from the foregoing examples. All references to examples hereinare intended to reference the particular example being discussed at thatpoint and are not intended to imply any limitation as to the scope ofthe disclosure or claims more generally. All language of distinction anddisparagement with respect to certain features is intended to indicate alack of preference for those features, but not to exclude such from thescope of the claims entirely unless otherwise indicated.

Recitation of ranges of values herein are merely intended to serve as ashorthand method of referring individually to each separate valuefalling within the range, unless otherwise indicated herein, and eachseparate value is incorporated into the specification as if it wereindividually recited herein. All methods described herein can beperformed in any suitable order unless otherwise indicated herein orotherwise clearly contradicted by context.

Accordingly, this disclosure contemplates the inclusion of allmodifications and equivalents of the subject matter recited in theappended claims as permitted by applicable law. Moreover, anycombination of the above-described elements in all possible variationsthereof is contemplated unless otherwise indicated herein or otherwiseclearly contradicted by context.

What is claimed is:
 1. A prosthesis adapted to be inserted into an earcanal in an ear having a tragus for treating discomfort in a jointbetween a mandible and a corresponding temporal bone, wherein the earcanal includes an isthmus, the prosthesis comprising: a substantiallyrigid and incompressible structural body adapted to conform to a contourof an interior surface of a portion of the ear canal which extendsbetween an entrance to the ear canal and the isthmus when the joint isin an open position, wherein said structural body is hollow along itslength, the structural body including a proximal base portion adaptedfor positioning adjacent the entrance of the ear canal, the structuralbody further including a distal end portion adapted to extend aneffective distance into the ear canal to treat discomfort in the joint,wherein a scalloped indenture is cut out from the structural body andextends away from a boundary edge of the proximal base portion across asurface of the structural body and is adapted for positioning behind thetragus of the ear.
 2. The prosthesis as recited in claim 1, wherein saidstructural body is formed from acrylic.
 3. The prosthesis as recited inclaim 1, further including at least one post element projecting awayfrom the proximal base portion, the post element adapted to extend to aposition outside of the ear canal when the prosthesis is inserted withinthe ear canal.
 4. The prosthesis as recited in claim 3, wherein saidpost element is formed from a thermoplastic polymeric or non-polymericmaterial.
 5. The prosthesis as recited in claim 4, wherein said postelement is formed from monofilament nylon.
 6. The prosthesis of claim 1,further comprising at least one compressible, cushioning layer around atleast a portion of said structural body.
 7. The prosthesis of claim 1,wherein said proximal base portion has a greater diameter than saiddistal end portion.
 8. The prosthesis of claim 1, wherein saidprosthesis is configured to be held in nested relation relative to theinterior surface of the ear canal.
 9. The prosthesis of claim 1, whereinsaid scalloped indenture has a length and width suitable to accept andsurround the tragus thereby facilitating a bending inwardly of thetragus towards the entrance of the ear canal without obstruction. 10.The prosthesis of claim 1, wherein said proximal base portion includes apeninsular leg adapted to project downwardly.
 11. A method of treatingdiscomfort in a joint between a mandible and a corresponding temporalbone, the method comprising: inserting the prosthesis of claim 1 into anear canal in an ear having a tragus, wherein the ear canal includes anisthmus.
 12. The method as recited in claim 11, wherein the structuralbody is free from any covering.
 13. The method as recited in claim 11,wherein said structural body is formed from acrylic.
 14. The method asrecited in claim 11, wherein said scalloped indenture is characterizedby a length and width sufficient to accept and surround the tragus ofthe ear.
 15. The method as recited in claim 11, wherein the prosthesisfurther includes at least one post element projecting away from theproximal base portion, the post element extending to a position outsideof the ear canal when the prosthesis is inserted within the ear canal.16. The method as recited in claim 15, wherein said post element isformed from a thermoplastic polymeric material.
 17. The method asrecited in claim 16, wherein said post element is formed frommonofilament nylon.
 18. The method as recited in claim 11, wherein theproximal base portion further includes an extended peninsular legportion adapted to extend into an inter-tragal notch.
 19. The method asrecited in claim 18, wherein the prosthesis further includes at leastone post element projecting away from the extended leg portion, the postelement extending to a position outside of the ear canal when theprosthesis is inserted within the ear canal.